Medication info
Mediroten Tablets 10/160 milligrams

Mediroten Tablets 10/160 milligrams

Prescription medicationTablet경구
Ingredient · strength
Valsartan›160mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
Bright yellow oval film-coated tablet
Packaging
28 tablets/box [14 tablets/PTP x 2]
Approval status
Active

MFDS item code 201308480 · Approved 2013.07.30 · Insurance code 646003740

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is one tablet once a day, to be taken with water regardless of meals. It is recommended to take it at the same time daily (e.g., in the morning). In patients with mild to moderate kidney impairment, dose adjustment is not necessary, but it should not be administered to patients with severe kidney impairment or those on dialysis. For patients with liver impairment, the daily dose of valsartan should not exceed 80mg. Elderly patients aged 65 years and older should be cautious during dose escalation.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, so its use is not recommended.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

Amlodipine and valsartan are both medications that lower blood pressure. They are used together when blood pressure control is difficult with just one medication in patients with essential hypertension, thus helping to effectively control blood pressure. The combination therapy of these two medications plays an important role in hypertension management and contributes to the prevention of cardiovascular complications. Therefore, this medication is used in the treatment of essential hypertension patients who do not achieve sufficient blood pressure control with monotherapy of either amlodipine or valsartan.

How to take

Adult dose

The recommended dosage of this medication is one tablet once a day, to be taken with water regardless of meals. It is recommended to take it at the same time daily (e.g., in the morning). In patients with mild to moderate kidney impairment, dose adjustment is not necessary, but it should not be administered to patients with severe kidney impairment or those on dialysis. For patients with liver impairment, the daily dose of valsartan should not exceed 80mg. Elderly patients aged 65 years and older should be cautious during dose escalation.

Child dose

The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, so its use is not recommended.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Patients with allergies to any of the ingredients in this medication or those who are pregnant or breastfeeding, as well as patients with severe kidney or liver disease and certain heart diseases, should not take this medication. Patients with insufficient sodium or fluid in the body should correct their conditions before taking this medication, and after starting the medication, blood pressure and condition should be closely monitored. Patients with high potassium levels or kidney problems should use caution when taking this medication together with potassium-increasing agents, and regular blood tests are recommended. As this medication has blood pressure-lowering effects, if symptoms of hypotension occur, the patient should be laid down and intravenous therapy should be applied if necessary, and treatment can continue after the symptoms stabilize. If angioedema occurs, this medication should be discontinued immediately and should not be reused. Patients with heart failure or after myocardial infarction should take this medication carefully while regularly evaluating kidney function changes. This medication can cause dizziness or fatigue when driving or operating machinery, so caution is advised. In particular, this medication may interact with other antihypertensives, potassium supplements, and some anti-inflammatory drugs, so it is essential to consult with healthcare providers regarding concomitant medications. Women who are pregnant or planning to become pregnant should not take this medication, and breastfeeding women are also not recommended to use it. The safety and efficacy of this medication in pediatric patients have not been adequately established, so it is not recommended. In case of overdose, symptoms such as hypotension or cardiac arrhythmias can occur, so it is important to adhere to the prescribed dosage and to inform a healthcare provider immediately if any adverse symptoms appear.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, peeling skin, pain in mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attack, cough accompanied by fever and respiratory distress, yellowing of skin or eyes (jaundice), profound weakness, sudden and severe headache, lightning-like headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Nasopharyngitis
  • influenza
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • sensory disturbances
  • vertigo
  • tinnitus
Show 27 more
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • limb edema
  • facial edema

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. This will help preserve the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Bright yellow oval film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP x 2]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.